JP4429310B2 - Acoustic telemetry device for in-body communication - Google Patents

Abstract

The invention relates to a system for providing communication within a patient's body, comprising: a first implant including a first acoustic transducer; and a second implant, including: an electrical circuit configured for performing one or more commands; an acoustic switch coupled to the electrical circuit and operable to activate the second implant between an active state and a dormant state; a second acoustic transducer coupled to the switch and configured to receive one or more acoustic signals transmitted from the first acoustic transducer, wherein the acoustic switch closes and causes the second implant to change from the dormant state to the active state in response to the one or more acoustic signals from the first acoustic transducer; and a sensor coupled to the electrical circuit, the sensor configured for measuring at least one physiological parameter within the body and transmitting a physiological data signal to the first implant when the second implant is in the active state.

Description

  The present invention relates generally to an apparatus for implantation in a patient's body, and in particular, uses one implant in the body to monitor physiological conditions and / or provide therapeutic functions. A system for communicating within a patient's body using acoustic telemetry that activates, deactivates and / or controls one or more additional implants placed within the body.

  The device can be implanted in the patient's body to monitor one or more physiological conditions and / or provide therapeutic functions. For example, sensors and transducers can be placed deep within the body to monitor various properties such as temperature, pressure, strain, fluid flow, chemical properties, electrical properties, magnetic properties, and the like. In addition, devices that perform one or more therapeutic functions such as drug delivery, defibrillation, or electrical stimulation can be implanted.

  Once such a device is implanted, it may be desirable to control the device or communicate with the device, for example, to obtain data and / or to activate or deactivate the device. Some implants have wire leads that extend from the implant to the patient's outer surface, which allows an external controller or another device to be directly connected to the implant. Alternatively, an external guidance device can be used to remotely control the implant or communicate with the implant. For example, an external radio (RF) transmitter can be used to communicate with the implant. In addition, RF devices have been proposed that can be implanted in a patient's body and communicate with another implant at a different location in the patient's body.

  However, because the body is dielectric, RF energy only reaches a few millimeters within the body and therefore cannot communicate effectively with implants located deep within the body. In general, the FR device consumes electric energy even when it is in a sleep state, and thus substantially requires electric power. Further, although an RF transmitter can induce current in the implant, the voltage generated by the implant's receiving antenna, typically a low impedance coil, is too low to provide a reliable switching mechanism.

  Since the body does not normally attenuate the magnetic field, magnetic energy can alternatively be used to control or communicate with the implant. However, the presence of an external magnetic field that a patient encounters during normal activities exposes the patient to the risk of false detection, i.e., accidental activation or deactivation of the implant. Furthermore, external electromagnetic systems are cumbersome and cannot effectively transmit information encoded in the implant.

SUMMARY OF THE INVENTION The present invention is generally surgically or otherwise placed in the body to monitor one or more physiological parameters and / or perform one or more therapeutic functions. It relates to an implant that can. In particular, the present invention relates to implants within a patient's body using acoustic telemetry that activates, deactivates and / or controls another implant placed within the body, for example, using one implant within the body. It is related with the system which performs communication between. One or both implants can monitor physiological conditions and / or provide therapeutic functions. The implant of the present invention can be used in, for example, ventricular defibrillation, pacing, pain relieving stimulation, nerve stimulation, drug administration, activation of light source for photodynamic therapy, monitoring of radiation administration including ionization, magnetic or acoustic emission, and bypass grafting. Measurement of various physiological parameters including flow monitoring, cellular oxygenation and membrane electrolysis delivery, ventricular pressure, infrastructure temperature, intracranial pressure, electrical impedance, position, orthopedic implant strain / displacement, pH, etc. It can be used for various medical and / or therapeutic functions.

  In one embodiment of the present invention, a system for communication within a patient's body is provided that includes a first implant called a control implant and a second implant called a dormant implant. Optionally, the system comprises one or more additional implants, such as one or more additional dormant implants, and / or the system includes a therapeutic device for treating the patient. Also good. Generally, the first implant has a first acoustic transducer that transmits an acoustic signal. The first implant may be, for example, a processor, controller, and / or other electrical circuitry, memory, energy source (eg, non-rechargeable or rechargeable battery, and / or capacitor), one or more sensors. And / or other members such as a treatment device. The second implant is typically an electrical circuit configured to execute one or more commands when the implant is activated; a switch connected to the electrical circuit; and a switch connected to the switch A second acoustic transducer, wherein the acoustic transducer receives one or more acoustic signals from the first acoustic transducer and closes a switch to activate the second implant. It is configured.

  Preferably, the switch is configured such that the switch closes only when the second acoustic transducer receives the first acoustic excitation signal and then receives the second acoustic excitation signal; The second acoustic excitation signal is divided by a predetermined delay. This signal configuration may be used, or other signal configurations may be used, for example when it is desired to activate one of a plurality of available dormant implants controlled by the first implant. Also good.

  In one embodiment, the second implant comprises a sensor connected to the electrical circuit, and the sensor is configured to measure a physiological parameter in the body when the second implant is activated. Yes. The second acoustic transducer may be configured to send a signal comprising physiological data related to the measured physiological parameter to the first acoustic transducer. For example, the first implant may comprise a controller connected to a pacemaker and the second implant may comprise a pressure sensor that measures the pressure of the patient's heart. The second implant is configured to transmit an acoustic signal to the first implant, and the acoustic signal may include the pressure in the patient's heart measured. The controller can be configured to extract a measured pressure from the acoustic signal and control the pacemaker at least in part based on the measured pressure.

  In another embodiment, the first implant comprises a controller connected to an insulin pump and the second implant comprises a glucose sensor for measuring blood glucose concentration in the patient's body. The second implant can be configured to transmit an acoustic signal to the first implant, the acoustic signal including a measured blood glucose concentration in the patient's body. The controller is configured to extract the measured blood glucose level from the acoustic signal and to control the insulin pump at least partially based on the measured blood glucose level.

  In yet another embodiment, the second implant includes a sensor that measures a physiological parameter in the patient's body. The second implant is configured to transmit an acoustic signal to the first implant, the acoustic signal including data regarding the measured physiological parameter. The first implant may comprise a memory for storing data relating to the measured physiological parameter and a transmitter for transmitting this data to a device located outside the patient's body.

  The first implant may store data regarding the physiological parameter in the memory of the first implant, for example, with a time stamp identifying when the parameter was measured for later retrieval. For example, an external device external to the patient's body can send a response signal to the first implant, which transmits one or more acoustic or electromagnetic signals containing data relating to physiological parameters. be able to. In addition or alternatively, the first implant can control a treatment device such as, for example, an insulin pump, pacemaker, etc. based at least in part on data related to physiological parameters.

  In one embodiment, one or more acoustic signals are transmitted from a control implant implanted in the body to activate a dormant implant located at a location in the body. The physiological parameter is measured at a location where the dormant implant is present, and one or more acoustic signals include physiological parameter data measured at the dormant implant. The control implant can store this data in memory. Optionally, the control implant can activate a plurality of dormant implants placed in the body, where each dormant implant measures a physiological parameter and transmits one or more acoustic signals to the control implant. . The one or more acoustic signals include physiological parameters measured with the dormant implant. Subsequently, the control implant sends a command signal using an external device placed outside the body, where the control implant receives data including physiological parameter data (one or more if there are multiple dormant implants). Transmit to external device (from further dormant implants) using, for example, acoustic telemetry or RF telemetry.

  For example, a dormant implant can measure pressure in, for example, a patient's aorta, kidney, or iliac artery. The pressure data is transmitted to the external device by the control implant and this data is used by the health care professional to monitor the patient's condition. In other embodiments, the patient's heart can be electrically stimulated based at least in part on the pressure data measured by the dormant implant. For example, a dormant implant can be implanted in the ventricle or pulmonary artery. The control implant can be included in or connected to the pacemaker to control the pace provided by the pacemaker. In yet another embodiment, the dormant implant may measure blood glucose concentration at a location within the patient's body and send one or more signals to the control implant. The one or more acoustic signals include blood glucose concentration data measured by a dormant implant. Insulin can be delivered into the body based at least in part on the blood glucose concentration measured by the dormant plant, for example using an insulin pump connected to or including the control implant.

  Thus, the system of the present invention can facilitate in-vivo communication between two implants using an acoustic telemetry device. Here, one implant acts as a master implant to control the operation of the second (or additional) implant. The first implant can switch the second passive implant to an active state via an acoustic command, where a series of predefined activities including therapeutic and / or diagnostic functions can be performed. At any stage of its operation, the second implant can communicate with the first implant, ie transmit and / or receive information. For example, the second implant can be controlled using optical dynamic therapy or ultrasonic activation to activate the drug or open the drug reservoir.

  Via the communication bus, the second implant is for example pre-programmed, externally controlled, or receives commands relating to medication or other parameters by feedback from sensors that monitor the relevant physiological parameters Can do. The sensor can be included, for example, in either the implant in communication with the first implant or the third implant. Alternatively, the second implant may be physiological or physical, such as pressure, blood clotting, acidity level (pH), temperature, flow, impedance, glucose, potassium, light decay, acceleration, oxygen saturation, drug concentration, etc. It can also be operated as a sensor for a dynamic parameter.

  Other objects and features of the present invention will become apparent from the following description taken in conjunction with the accompanying drawings.

Referring to the description drawings showing the embodiments, FIG. 1 shows an embodiment of a body communication system 10 between two or more implants were implanted in the patient's body (not shown). In general, the system 10 comprises a first implant 12 (so-called control implant or master implant) and a second implant 32 (so-called dormant implant or slave implant). Optionally, the system 10 is similar to the second implant 32, such as, for example, one or more additional dormancy or slave implants, and as described below, an additional implant (not shown) with which the control implant can communicate. May be included.

I. Control Implant Control implant 12 includes a plurality of components, such as an electrical circuit 14, an acoustic transducer 16, and / or an energy source 18, which are provided within a box or casing 20. The casing 20 is made of, for example, titanium and is substantially enclosed and preferably sealed to substantially isolate the components of the control implant 12 from the outside of the casing 20. The casing 20 includes one or more regions, such as one or more side panels, and acoustic energy passes through the casing 20, i.e. to and / or from the acoustic transducer 16. Makes it easy to pass. For example, the panel 20a overlying the acoustic transducer is a relatively thin wall made of titanium or other material, for example about 0.5 mm thick, that allows sound waves to substantially pass therethrough. More information on how all implants described herein can be constructed can be found in US patent application Ser. No. 09 / 888,272, filed Jun. 21, 2001.

  The electrical circuit 14 may be connected to an energy source 18 so that at least some components of the electrical circuit 14 are always activated, but alternatively all or part of the electrical circuit 14 may be periodically May be made to sleep and / or selectively activated. The electrical circuit 14 generates a control implant 12, a timer circuit (eg, a clock or counter), an oscillator or other circuit that drives the first acoustic transducer 16, and / or generates an electrical signal to be transmitted, and / or A processor (not shown) is provided for analyzing the electrical signal received from the first acoustic transducer 16.

  Further, the control implant 12 may comprise a memory 22 such as a volatile or non-volatile memory, including a flash memory or a ferroelectric memory. The memory 22 may, for example, receive data from one or more sensors (not shown) of the control implant 12 and / or the dormant implant 32 and / or commands for internal use or control of the dormant implant 32. , Etc. can be stored. Optionally, the control implant 12 may comprise a transmitter and / or receiver 24, such as a radio (RF) or acoustic transmitter and / or receiver, for communication with an external device (not shown). . The circuitry 14 of the control implant 12 may include one or more microcontrollers, digital signal processors (DSPs), field programmable gate arrays (FPGAs), other programmable devices, and / or processing, analysis, and / or data Other hardware components or software modules necessary for storage and / or control of the operation of the control implant 12 and / or the dormant implant 32 may be provided.

  Optionally, control implant 12 may comprise an acoustic switch (not shown) for activating and / or deactivating control implant 12 during use. In addition, or alternatively, the control implant 12, as described below, as well as the dormant implant 32, may include one or more sensors (not shown) for measuring or monitoring one or more physiological parameters. ). In addition or alternatively, the control implant 12 may comprise an actuator (not shown) for operation of a therapeutic and / or diagnostic device connected to the control implant 12. Examples of implants comprising acoustic switches, sensors and / or actuators are described in US patent application Ser. No. 10 / 152,091, filed May 20, 2002, 09/09, filed Nov. 19, 2001. No. 989,912, 09 / 888,272 filed Jun. 21, 2001, and US Pat. No. 6,628,989.

  The acoustic transducer 16 typically comprises one or more piezoelectric elements (not shown) configured to transmit one or more acoustic signals, for example, comprising activation or deactivation commands. The acoustic signal reaches the dormant implant 32. In addition, the acoustic transducer 16 includes one or more piezoelectric elements (not shown) that receive one or more acoustic signals, eg, from the dormant implant 32 and / or from an external device (not shown). May be. Those skilled in the art will appreciate that the same or different piezoelectric elements can be used for transmitting and receiving acoustic signals.

  The acoustic transducer 16 can emit sound waves or signals that reach one or more dormant implants 32. For example, the acoustic signal performs an activation signal for activating one or more dormant implants, one or more deactivation signals, and / or a sequence of operations performed, for example, by a dormant implant. Alternatively, a command may be provided to program or direct the dormant implant to deform it. In addition, the acoustic transducer 16 can be used for communication with an external device such as a controller or recorder (not shown) and / or as an energy exchanger, ie, an external charger that can be used to recharge the control implant 12. Can be used to receive acoustic or electromagnetic energy from

  An exemplary embodiment of the control implant 12 is shown in FIGS. 2A and 2B, which includes an acoustic transducer 16 integrated within a sealed casing 20. Another embodiment of the control implant 112 is shown in FIG. 3 where the acoustic transducer 116 is a piezoceramic cylinder provided at the tip of the lead 126. According to this configuration, the control implant 112 can be integrated into an existing medical implant with minimal deformation, such as a pacemaker. This is because the acoustic transducer 116 can be attached to the outer surface of the casing 120 that includes the components of the implant 112.

である。
ここで、“ρ”と“ｃ”は、それぞれ、水中の密度及び音速であり、“Ｒ”は距離、“ｐ”は所望の音圧である。電気−音響変換効率を２０％とすると、この式は約１００ｍＷの必要瞬間電力を提供する。 A. Exemplary Call Signal Energy Needs The following description relates to energy consumption parameters and, as a result, for a control implant such as the control implant 12 shown in FIGS. 1, 2A and 2B, an energy such as a battery. Specifically, power is required as a source. Acoustic energy exchangers or transducers can currently achieve a sensitivity of about 2 V / kPa. An acoustic switch that can be used to activate the implant operates by closing a MOSFET that requires about 0.5V in the case of a silicon piezoelectric element. Accordingly, the minimum sound level required to close the acoustic switch is about 250 to 500 Pascals (250-500 Pa). Assuming that the distance between the transmitter and the receiver is about 10 cm (ie, the distance between the controlling acoustic transducer and the dormant implant implanted in the patient's body), the acoustic power producing 500 Pascals (500 Pa @ 10 cm) is :

It is.
Here, “ρ” and “c” are the density and sound velocity in water, “R” is the distance, and “p” is the desired sound pressure. Given an electro-acoustic conversion efficiency of 20%, this formula provides the required instantaneous power of about 100 mW.

It is also possible to close this switch using only a single acoustic vibration. However, this is not practical because it requires a very wide tondrath reducer and matching network. More realistic is a pulse length of about 5 to 10 (5-10) vibrations, and 10 vibration pulses at 40 kHz are about 250 μs long. Thus, the energy consumed by such a pulse is:
E = 250 × 10 ⁻⁶ × 0.1 = 25 μJ (2)
It is.

A typical call signal consists of 1 to 4 pulses. Therefore, if there is one call per hour, the energy drain is P = 25 × 10 ⁻⁶ × 4/3600 = 0.028 μW (3)
It becomes.

  Furthermore, the power required for the receiver must be taken into account. An amplifier with the required sensitivity requires about 10 mW of power. If power is supplied for 1 second every hour, it means an average power drain of about 2.8 μW. This power is at least 2-10 by using more aggressive power management, for example, reducing the power of the amplifier between words and / or concentrating on a specific pressure waveform segment such as the systole Can be reduced by a factor. The power required for this may be substantially greater than the power from the transmission itself. Therefore, the power drain of this interrogation circuit is on the order of about 1 μW.

B. Exemplary transmitter / receiver element (acoustic transducer)
The acoustic transducer of the control implant (calling transducer) can be constructed in various ways. One example is a piezoelectric ceramic cylinder described in FIG. This product is sold as PIC181 PZT by Physik Instrumente (PI) GmbH & Co. KG, Karlsruhe, Germany. This cylinder expands or contracts under the influence of an applied AC voltage. This changes the volume of the cylinder and sends an acoustic signal to all surrounding liquids as a single (ie monopole) source.

である。
ここで、“λ”は音波長であり、“Ｖ”は素子の体積である。４０ｋＨｚで５００Ｐａ＠１０ｃｍの必要な音響レベルを得るには、約２．５×１０^−６ｍ^３／ｓｅｃの体積変化か、あるいは約１０^−１１ｍ^３の体積変化幅が必要である。 The equation for the acoustic output of a monopole source with mechanical vibration is:

It is.
Here, “λ” is the acoustic wave length, and “V” is the volume of the element. In order to obtain a required sound level of 500 Pa @ 10 cm at 40 kHz, a volume change of about 2.5 × 10 ⁻⁶ m ³ / sec or a volume change width of about 10 ⁻¹¹ m ³ is required.

で与えられる。
ここで、“Ｓ”は歪である。１０^−１１ｍ^３の体積変化を得るには、約４×１０^−６の歪が必要である。ＰＩ社のPIC181 PZT は、圧電歪定数が１２０×１０^−１２m/m／_V/mである。したがって、４×１０^−６の歪を得るには、約３３，０００Ｖ／ｍの電界を与えなければならず、さもなければ、約１ｍｍの壁厚に対して約３３Vの振幅が必要である。 For example, assume that the transmitter is a ceramic cylinder having a length of about 10 mm (L = 10 mm), a radius of about 2.5 mm, and electrodes on its inner and outer surfaces. Since ceramic materials are isotropic, when a voltage is applied, the material expands in the tangential and axial directions as well. The overall volume change is:

Given in.
Here, “S” is distortion. To obtain a volume change of 10 ⁻¹¹ m ³ , a strain of about 4 × 10 ⁻⁶ is required. PI's PIC181 PZT has a piezoelectric strain constant of 120 × 10 ^{−12 m / m} / _{V / m} . Therefore, to obtain a strain of 4 × 10 ⁻⁶ , an electric field of about 33,000 V / m must be applied, otherwise an amplitude of about 33 V is required for a wall thickness of about 1 mm.

  The battery that provides this energy can be of various types used in other active implantable devices such as defibrillators, pacemakers, neural stimulators, etc. For example, the battery may be a lithium polymer, lithium iodide, lithium ion and / or nickel metal. Assuming that the acoustic transducer is used to activate the dormant implant every hour, the average power is about 1 μW, which is less than the power used in conventional pacemakers.

II. Dormant Implant Returning to FIG. 1, an exemplary embodiment of a second or dormant implant 32 is shown. Generally, like the control implant 12, the dormant implant 32 comprises a plurality of parts, such as, for example, an electrical circuit 34, an acoustic switch 42, and / or an energy source 38, which are housed in a casing 40. ing. The casing 40 is made of titanium, for example, and is sealed or otherwise sealed to substantially isolate the parts of the dormant implant 312 from the exterior of the casing 40. The casing 40 includes one or more regions that facilitate the passage of acoustic energy through the casing 40. For example, the panel 40a above the acoustic transducer 36 may be a membrane made of relatively thin titanium, or other material about 50 μm thick or less, through which sound waves pass.

  The acoustic switch 42 is connected to the electric circuit 34 and the energy source 38. The acoustic switch 42 is activated, for example, when there is an acoustic excitation from the control implant 12 by the external acoustic energy source, and a current flows from the energy source 38 to the electric circuit 34. In another embodiment, the acoustic switch 42 includes an energy transducer or acoustic transducer 36 and a switch circuit. Exemplary switch circuits and acoustic switches are disclosed in US patent application Ser. Nos. 10 / 152,091, 09 / 989,912, and 09 / 888,272, and US Pat. No. 6,628,989. Yes. Basically, acoustic transmission from the control implant 12 causes the acoustic transducer 36 of the dormant implant 32 to vibrate, creating a voltage pulse that is applied to the switch circuit 44. When the voltage exceeds a predetermined threshold of, for example, 0.5V, the switch circuit 44 closes and current flows from the energy source 38, thereby activating the implant 32.

  The energy source 38 may comprise a variety of devices such as energy exchangers, batteries, and / or capacitors (not shown). Preferably, the energy source 38 is a battery capable of storing electrical energy substantially indefinitely, for example when the acoustic switch 42 is in an open state, i.e. when the dormant implant 32 is in "sleep" mode. . Furthermore, the energy source 38 may be able to be charged from an external source, for example inductively, using the acoustic energy received by the acoustic transducer 36.

  In another embodiment, the energy source 38 may comprise a capacitor and a primary battery that cannot be recharged. Alternatively, the energy source may be a rechargeable secondary battery and / or capacitor that is energized prior to activation or use of the dormant implant 32. For example, energy source 38 comprises a lithium thin film battery available from Oak Ridge Micro-energy Inc., Salt Lake City, Utah, Infinite Power Supply, Denver, Colorado, and Cyber Corporation, Elk River, Minnesota. It may be. Alternatively, the energy source 38 may comprise a standard coin-type manganese lithium rechargeable battery available, for example, from Matsushita Battery Industry (MBI), Osaka, Japan.

  Optionally, the dormant implant 32 may comprise other components for performing various monitoring, diagnostic, and / or therapeutic functions. For example, the electrical circuit 34 may include a control unit, a memory, a biosensor, an actuator, and / or a transmitter (all not shown). These details are described below. The dormant implant 32 may be implanted in the patient's body, such as a light source used for ventricular defibrillators, pacemakers, pain relief stimulators, neural stimulators, drug delivery devices (eg, insulin pumps), and / or optical dynamic therapy. Can be configured to provide one or more therapeutic functions that activate and / or control the treated therapeutic device. Alternatively, the implant 32 can be used to ionize, monitor magnetic and / or acoustic radiation, monitor flow within the bypass graft, perform cellular oxygenation and membrane electroporation, etc. . Additionally or alternatively, the implant 32 may measure one or more physiological parameters such as pressure, temperature, electrical impedance, position, strain, fluid flow, pH, etc. within the patient's body. The sensor may be provided.

  For example, the implant 32 may comprise a biosensor having one or more sensors capable of measuring the physiological parameters described above. U.S. Pat. Nos. 4,793,825 and 5,833,603 disclose exemplary embodiments of biosensors that can be included in an implant according to the present invention. This biosensor generates a signal proportional to the physiological parameter. This signal is processed and / or sent to the acoustic transducer 36 by the electrical circuit 34 to generate a transmission signal that is received by the control implant 12.

  Additionally or alternatively, for example, a light source, a neurostimulator, a defibrillator, or an implanted drug reservoir (within or within the implant) provided in or connected to the implant 32 There may be an actuator (not shown) connected to a physiological device (not shown) such as a valve in communication with (implanted in the body associated with). For example, the actuator may be a light source for optical dynamic therapy as disclosed in US Pat. No. 5,800,478.

  Accordingly, the second implant 32 may continue to sleep and be activated when an acoustic signal is received that provides a voltage high enough to close the acoustic switch 42. In the dormant state, the second implant 32 consumes little or no energy and can remain in the body almost permanently.

  Once activated, the acoustic transducer 36 converts, for example, an acoustic signal received from the control implant 12 into one or more electrical signals. This signal is processed by the electrical circuit 34 or used to control the operation of the dormant implant 32. The acoustic transducer 36 can also be used to charge an energy source 38 such as a rechargeable battery and / or a capacitor. Similar to the control implant 12 described above, the acoustic transducer 36 may include one or more piezoelectric elements that can be used to receive an acoustic signal and transmit the acoustic signal.

  FIG. 4 shows an exemplary sequence of operations performed in a system such as system 10 shown in FIG. First, the control implant 12 and the second implant 32 are implanted at different locations within the patient's body, leaving the second implant 32 in a passive or “sleep” mode. In step 60, the acoustic transducer 16 of the control implant 12 transmits one or more acoustic signals including activation commands, which are received by the acoustic transducer 36 of the second implant 32. If the acoustic signal satisfies the threshold of the acoustic switch 42, the switch 44 is closed, thereby activating the second implant 32.

  For example, the acoustic switch 42 is activated only when a specific sequence of acoustic signals is received, for example, a start pulse after a predetermined delay due to a confirmation pulse. Such a sequence prevents false activation / deactivation and / or only one of a plurality of dormant implants (not shown), for example by assigning different dormant implant parameters to each dormant implant. Can be used to activate. The use of a confirmation signal is particularly important for certain applications, such as preventing unintended drug release by the drug delivery implant. In addition, the activation signal and / or the confirmation signal may be of a unique configuration, such as activating a single selected dormant implant 132 if multiple dormant implants 32 are implanted in the patient's body 90, for example. be able to.

  Once the second implant 32 is activated, the acoustic transducer 36 converts the acoustic signal into one or more electrical signals, and the electrical circuit 34 of the second implant 32 analyzes the electrical signals. For example, the electrical circuit 34 extracts one or more commands from the signal and controls the implant 32 to complete the commands. Alternatively, the second implant 32 may be pre-programmed and a predetermined sequence of operations may be automatically executed once activated. This sequence may activate one or more sensors to obtain physiological data associated with the patient and / or activate a therapeutic and / or diagnostic device connected to the second implant. It is also included.

  In step 70, the acoustic transducer 36 of the second implant 32 returns one or more acoustic signals including data to the control implant 12. This includes associating physiological data obtained from one or more sensors with a time stamp and converting the data into a signal transmitted by the acoustic transducer 36. In addition, the acoustic signal may comprise operating parameters of the second implant 32 and / or a device (not shown) connected to the second implant 32. The acoustic transducer 16 of the control implant 12 receives the acoustic signal and converts the acoustic signal into one or more electrical signals. The electrical circuit 14 of the control implant 12 extracts physiological data or other information generated by the second implant 32 from this signal. The control implant 12 can store the data in an external recorder and / or controller for later retrieval and / or transmission, for example. In addition, the control implant 12 uses this data to provide another implant (not shown) connected to the control implant 12, for example, directly with one or more leads, or indirectly via an acoustic remote device. ) Can be controlled. For example, the control implant 12 sends a response signal to the second implant 32 to obtain data related to the patient's physiological data and then controls another implant device, such as a pacemaker or insulin pump. Can be operated in a certain way.

  If the second implant 32 is configured to operate continuously and / or permanently in step 80, the control implant 12 deactivates the second implant 32 after obtaining sufficient data. One or more acoustic signals can be transmitted. Similar to the activation signal described above, the deactivation signal includes a start pulse followed by a confirmation pulse, or a confirmation pulse or other sequence necessary to ensure that the appropriate implant responds appropriately. Once an inactivation signal is received at the second implant 32, the switch 44 opens to return the second implant 32 to sleep mode. Alternatively, the implant 132 may provide a timer (not shown) so that when the switch 44 is activated, the implant 132 is closed for a predetermined period of time, for example, monitoring pressure continuously or intermittently. May automatically open the switch and change the implant 132 to sleep mode.

III. Exemplary Embodiment A. Measuring Physiological Pressure In one embodiment, a dormant implant such as implant 32 shown in FIG. 1 can be used to monitor the physiological pressure at a location within the patient's body where the dormant implant is implanted. For such applications, the dormant implant 32 may include a pressure sensor (not shown) connected to the electrical circuit 34. This pressure sensor is housed within the implant 32, i.e., with an active sensor probe under pressure in the patient's body, but alternatively the pressure sensor may be connected to the implant 32 with one or more leads, for example. (In either case, the pressure sensor is referred to as “internal pressure sensor” in this case).

  Since the internal pressure sensor can measure absolute pressure, it may be necessary to determine the patient's physiological pressure within the patient's body, i.e., gauge pressure, from the measured absolute pressure. To do this, the patient may carry an “external” pressure sensor (not shown) for measuring ambient atmospheric pressure. This external pressure sensor can specify and / or store a time stamp that uniquely identifies, for example, time, date, etc. when the pressure is measured, along with any measured pressure. This sensor may comprise a timer and / or memory and can easily record the time of the atmospheric pressure data. Alternatively, the dormant implant 32 and / or the control implant 12 may specify a time stamp in the barometric data obtained from the external pressure sensor.

  For example, the external pressure sensor can be secured outside the patient's skin, such as a patch, belt, or other external environmental pressure outside the patient's body. Control implant 12 and / or dormant implant 32 connect to an external sensor, for example directly via one or more leads, or indirectly via a wireless transmitter / receiver such as an acoustic or RF transducer. be able to. The control implant 12 or dormant implant 32 may, for example, use an internal clock to specify a time stamp in the barometric data and / or partially store the time stamp associated with the barometric data in memory. Also good.

  The dormant implant 32 is used to measure absolute internal pressure data using an internal pressure sensor. The dormant implant 32 assigns a time stamp to all internal pressure data and sends the time stamp to the control implant 12 along with the associated internal pressure data. The control implant 12 subtracts the air pressure (obtained from the external sensor) from the absolute pressure (obtained from the internal sensor) with the same time stamp to retrieve the desired physiological pressure at the time identified by that time stamp. The control implant 12 can store any data, such as physiological pressure data and / or other data, locally in memory for later use and / or monitor treatment parameters associated with the patient. And / or changing data can be used.

  In another embodiment, a barometric sensor (not shown) is implanted in the patient's body, such as subcutaneously near the control implant 12. Subcutaneous sensors are connected to the control implant 12, for example directly (via one or more leads or via the pressure lumen of a catheter configured to transfer pressure) or indirectly (acoustic remote). The measurement method or other wireless communication link) may be used in the same manner as the external sensor described above. Alternatively, if the control implant 12 is implanted subcutaneously or otherwise near the skin, a barometric sensor may be used, for example, under the pressure sensitive area of the casing 20 of the control implant 12. You may make it include in. Subcutaneous pressure sensors do not provide an accurate measure of barometric pressure, but can predict barometric pressure sufficiently accurately to reasonably predict physiological pressure. Other barometric data acquisition devices, for example using a position finder, are disclosed in US patent application Ser. No. 10 / 152,091 and US Pat. No. 6,234,973.

  In another embodiment, system 10 is used to monitor pressure within a patient's cardiovascular system. For example, a single patient, i.e., control implant 12 or dormant implant 32, may be included and / or coupled within other diagnostic and / or therapeutic devices implanted within the patient's cardiovascular system, such as, for example, a pacemaker. Other implants can be implanted relatively close to the surface of the patient's body, eg, subcutaneously. For example, the control implant 12 may be placed subcutaneously and the dormant implant 32 may be implanted deeper in the patient's body, for example, within a blood vessel or near the patient's heart. In a deeper dormant implant 32, the energy source 38 is preferably a battery with sufficient power to operate intermittently for extended periods of time without recharging or replacing the dormant implant 32. The acoustic switch 42 sleeps the implant 32 for a long time until activated by the control implant 12 with little or no electrical energy, thereby minimizing energy consumption, It tries to extend its life.

To account for the energy required for a dormant implant, the energy consumption of an activated dormant acoustic implant is approximately 5 μA (1-5 μA). The required minimum operating time is as short as about 1 second. Assuming that the time to sample several heartbeats is 3 seconds (t = 3 seconds) and that about 10 pressure samples are needed per day, the total sampling period T for one year is about 3 hours (T = 3 × 10 × 365 = 10 ⁴ seconds to 3 hours). As a result, the amount of electric power consumed in one year in such pressure measurement is about 15 μampere hours (P _sampling = 15 μA · Hr).

A correctly operating acoustic switch has a leakage current of less than 1 nanoampere (1 nA). Assuming a leak rate of 1 nanoampere (1 nA), a year of leakage is approximately 9 μAh (P _leakage = 1 nA × 8760 Hr = 8.7 μA · Hr). Thus, the total power consumed by the dormant implant is approximately 24 μAh (24 μA · Hr), including the desired activation time and leakage.

The battery can be incorporated into the implant, even if it is incorporated, the size of the entire implant is 8 mm long, 2 mm wide, and 0.3 mm thick (8 mm x 2 mm x 0.3 mm, length x width x thickness) or less. Can be suppressed. For example, a thin film lithium battery that fits in this size has a thick cell capacity of 200 microamperes time square centimeter per 15 [mu] m thick ^{(200μA · Hr · cm- 2 /} 15μm). Assuming 10 layers of cells, the total capacity of this battery is 2000 μA · Hr · cm ⁻² . For a battery cell area of about 0.8 cm × 0.2 cm, the total capacity of the battery (assuming about 50% cathode efficiency) is about 160 μAh (P _battery = 0.8 × 0.2 × 1000 = 160 μA) Hr).

  This shows that the battery has a lifetime of 6 years or more, assuming 10 pressure samples per day. For example, if the battery can be recharged using acoustic energy transmitted using an energy exchanger such as the acoustic transducer 36 described above (and disclosed in US Pat. No. 6,140,740), this lifetime is It will extend further.

  Referring to FIG. 5, an exemplary embodiment of the system 110 is disclosed, which includes a control implant 112 and a plurality of dormant implants 132 that monitor the hypertension of the patient 90. Although two dormant implants 132 are shown, one or more implants 132 can be used depending on the number of points at which pressure is measured. The control implant 112 and / or the dormant implant 132 can be configured in the same manner as all the embodiments described above.

  Hypertension is currently the most widespread disease in the world and is said to affect 50 million people in the United States alone, with 1 million new patients every year. Occasionally there are no symptoms and 1/3 patients are unaware of their illness. Nonetheless, hypertension is strongly associated with a high risk of stroke, chronic heart disease (CHF), myocardial infarction (MI), kidney disease, and other health problems, and is the cause of many of these diseases. ing. The death rate directly attributable to hypertension was about 42,000 in the United States in 1997, and high blood pressure was a factor contributing to about 210,000 deaths.

  The regulation of blood pressure (BP) is based on a complex nerve-hormone balance and includes global and local regulation of substances that regulate hormone and heart function, systemic resistance, and kidney function. Feedback is provided by baroreceptors located in the atrium and in the carotid artery. Hypertension is defined by a systolic pressure of 140 mmHg or higher and / or a systolic pressure of 90 mmHg or higher. About 90 to 95% of people with high blood pressure are in the first phase. Hypertension is often discovered unexpectedly during routine BP measurements, but symptoms such as dizziness, headache, or visual impairment also occur. Of the approximately 50 million Americans with high blood pressure, about 32% are unaware of the condition, about 15% have mild hypertension and are not treated, and about 27% are treated However, about 26% of people receive treatment without proper control of BP.

  The treatment of hypertension is a complex task and addresses several points when regulating BP. However, this task is often difficult and half of patients undergoing treatment for hypertension do not have proper control of BP. Lack of control is highly associated with morbidity and mortality, which is a high cost for health care systems and health care societies.

  To monitor and / or treat hypertension, the patient's BP is regularly measured, for example, usually by a surgeon. In some cases, home measurements by patients may be substituted. However, regardless of whether or not this few measurements are made, treatment and measurements for successful treatment are based on random measurements that are made from time to time. Monitoring with a BP Holter device that records BP for 24 hours can create a broader clinical picture of the disease in patients without BP control. However, this device is not comfortable to use, is expensive, and cannot be used on a long-term basis, thus limiting its clinical application.

  In contrast, the system 110 shown in FIG. 5 can frequently measure a patient's BP over a long period of time. As shown, each dormant implant 132 can be implanted in an artery such as the iliac artery 92 or aorta 94 (these arteries are large in size and easy to access with minimal convenience, And / or can be more easily protected). Within the artery, the dormant implant 132 may periodically monitor the patient's BP, for example, at a frequency programmed by the patient's surgeon. For example, the control implant 112 can be programmed to implant each dormant implant 132 on a regular basis, such as to send a response command several times a day, for example. Alternatively, the control implant 112 can be periodically programmed using an external device (not shown). In this alternative, the control implant 112 may comprise a receiver, which may be the same acoustic transducer that is used to transmit and / or receive acoustic signals from the dormant implant. Alternatively, the control implant 112 may comprise a separate receiver that can communicate with an external device, such as an RF or acoustic transmitter / receiver.

  Each dormant implant 132 is no longer 9 mm long, 2 mm wide and 1 mm thick (9 mm × 2 mm × 1 mm, L × W × T). The dormant implant 132 may be implanted in the cavity using, for example, a catheter or sheath of about 7 French (7 Fr.) or less. This can be introduced percutaneously into, for example, a peripheral artery such as the femoral artery and advanced to the implantation site in a conventional manner.

  In one embodiment, the implant 132 may be secured within the artery using a skeletal structure or other securing methods such as a stent capable of securing the implant 132. Exemplary structures that can be used to deliver and / or deliver dormant implants are disclosed in US Pat. No. 6,442,413 or published in PCT application WO 99 / 34,731. Alternatively, a dormant implant may be applied to the graft structure for detecting internal leaks in an aneurysm as disclosed in pending patent application 09 / 522,724 filed March 10, 2000. You may make it attach. The implant 132 may be implanted in a dedicated process, for example, in conjunction with other processes such as a catheter process, such as a coronary catheter or peripheral intervention, or a minimal such as a coronary artery bypass. It can also be sutured into a blood vessel in conjunction with an invasive surgical or endoscopic process.

  The control implant 112 can be embedded at a different site from the pressure sensing implant, for example, at a sub-dermal site within the patient's abdomen. For example, this location can be accessed through a small skin incision about 2 cm long to create a pocket to receive the control implant 112.

  Once implanted, the control implant 112 periodically sends a response command to the dormant implant 132 to obtain BP data and send the data back to the control implant 132. At that time, the control implant 112 saves the data in memory (preferably with an associated time stamp). Optionally, in addition to the BP measurement, data related to the patient's movement may be obtained and stored, for example to relate the patient's BP to the patient's current movement level. For example, a single accelerometer sensor (not shown) made of silicon may be provided within the control implant or otherwise carried by the patient to monitor the patient's level of physical movement. In addition or alternatively, the system may determine the patient's posture when obtaining a BP to calculate the orthostatic correction factor.

  Control implants 112, such as regularly scheduled times, may be used to monitor patient status and / or change patient treatment, such as in a clinic, hospital, or other healthcare facility. Response command can be sent to receive data. To obtain this data, an external controller and / or recorder can be provided, similar to the description of the above-mentioned US patent applications and issued patents. The recorder is in contact with the patient's skin, i.e. in close proximity to the control implant 112, using for example an acoustic remote device and an acoustic transducer 116 or using other communication links such as an RF remote device, for example. The control implant 112 can be instructed to transmit BP data.

  Alternatively, a home based patient monitor, i.e., controller and / or recorder (not shown) may be used to send a response command to the control implant 112 to send BP data to the telephone, the Internet, or It can be transmitted to healthcare facilities via other communication systems. Alternatively, an external controller can be used to change the frequency and / or other parameters of the operations performed by control implant 112 and / or dormant implant 132. For example, the external controller may send a new parameter to the control implant 112, which may store it for future operation and / or send it to any dormant implant 132 for communication. May be.

  The BP data transmitted by the control implant 112 may include a total pressure pattern, or simply include one or more desired parameters such as systole, systole, and / or mean blood pressure. There may be. The collected data can provide a comprehensive clinical picture and treatment of the patient's illness, optimize the patient's drug prescription, and / or provide effective treatment for the currently uncontrolled patient. In addition, the frequency of visits and hospitalizations can be reduced, thereby reducing the cost of treatment for patients.

B. Heart Pressure Monitoring In another example, the system of the present invention can be used to monitor ventricular pressure and / or the pressure of large vessels in a patient's heart. The obtained data can be used to provide physiological feedback to devices such as pacing implants, for example, pacemakers and biventricular pacers, to optimize device performance. For example, a biventricular pacemaker (not shown) can control the delay between different ventricular contractions of the patient's heart to optimize the pumping efficiency of the heart. The dormancy transducer acts as a remotely controlled pressure sensor and transmits pressure data from a vessel, such as the pulmonary artery, left atrium, or left ventricle, to the biventricular pacemaker to provide feedback to the pacemaker. The dormant implant can also be used to measure pressure and transmit pressure data to improve defibrillator performance.

  An implantable cardioverter defibrillator (ICD) can be implanted in the chest to monitor early beating and correct its development if necessary. If the heart beats too early (ventricular frequency), the ICD electrically stimulates the heart to return to normal rhythm (anti-frequency pacing). If the heart beats quickly and the person dies (ventricular fibrillation), the ICD can apply an electric shock (defibrillation) to reset the heartbeat. To facilitate the determination of the mode of use of the ICD, the present invention is used to monitor the pressure in the ventricle to determine whether the patient has atrial fibrillation or ventricular fibrillation, for example. Systems and devices can be used. For example, a system is provided that includes one or more dormant implants implanted in a patient's left ventricle, left atrium, and / or pulmonary artery, similar to those described above. The control implant can be implanted subcutaneously, for example, by providing a small shallow incision in the chest of 2 to 3 cm in length, the control implant can be inserted and the incision can be closed with a suture. The control implant can be connected to the ICD directly or indirectly, as in the above example. Alternatively, parts of the control implant can be incorporated into the ICD.

  In use, the control implant can activate and send information to the control implant one or more dormant implants that measure the pressure within each heart region. This is similar to the embodiment described above, in which multiple dormant implants are activated alternately, sequentially and / or simultaneously, receiving pressure data and storing it in the memory of the control implant. including. Similar to the embodiments described above, healthcare professionals and / or patients can periodically download pressure data using an external device that communicates using acoustic or RF remote devices. Depending on the reading, the physician can make a decision regarding the appropriateness of the medical procedure that the patient will receive and, if necessary, make appropriate corrections, such as by reprogramming the patient's ICD, control implant, and / or dormant implant. This ensures better patient treatment, better use of medical resources and reduces the need for hospitalization.

  Alternatively, the system can automatically determine whether the ICD is simply stimulating or defibrillating. This is because these two major fibrillations require different treatments. One or more dormant implants can be provided in different ventricles of the patient's heart, for example to monitor its pressure. The control plant may be provided outside the heart, for example, by being attached to the pacemaker or provided in the pacemaker, and can selectively or periodically send a response command to the dormant implant to obtain output data. This data allows the control implant and / or pacemaker to determine the appropriate response to the patient's condition.

  Alternatively, the system of the present invention can be used to provide hemodynamic feedback for patients with congestive heart disease (CHF). Hemodynamic information, particularly pressure information, can be used to improve the treatment of CHF patients. CHF is a chronic and progressive disease that reduces the heart's pumping capacity and reduces the patient's ability to perform physical movements. The body implements various compensation mechanisms to offset pumping defects, and this is manifested when the compensation capacity is excessive. One of the overall prognosis of patients diagnosed with heart disease is a gradual deterioration of heart function, which eventually leads to death.

  Managing CHF is a complex challenge and involves balancing several drugs. This is an interaction and / or triggers a further compensatory response. Therefore, treating CHF is to balance the patient's hemodynamic state to the compensated state in order to slow the progression of the disease. The high balance of compensation easily breaks down, creating a non-compensation crisis. Current monitoring techniques are unable to prevent the onset of these symptoms, which report about 1 million hospitalizations annually in the United States, resulting in a total of about 6.5 million hospitalizations per year.

C. Providing a feedback loop for insulin administration Diabetes is the six leading cause of death in the United States, and the prevalence is growing rapidly. For millions of diabetics who are unable to cope with dietary changes themselves, continued control of these diseases is by monitoring blood glucose levels accordingly and treating with insulin. To do this, the diabetic must repeatedly perform a blood glucose or glucose test on the blood sample with a finger. Depending on the results, they have to do their own injection of insulin and return the glucose to an acceptable level. Failure to maintain adequate blood sugar levels can cause severe complications involving multiple body organs, progression of cardiovascular and renal disease, vision loss, and / or peripheral vascular disease.

  Despite this motivation to maintain proper glucose control, many patients consider endless finger sticks and insulin injections to be intolerable. Furthermore, for maximum effect, insulin should be administered as soon as necessary. However, this time can occur at inappropriate moments, such as during a meal, or it can be in a social environment that is disgraced in connection with the syringe or other device used to deliver insulin. is there. Thus, diabetics often have to compromise proper glucose control with convenience, social fit, and / or quality of life. These behaviors too often result in sub-optimal glycemic control, diminishing outlets for diabetics, and increasing hospitalization costs.

  However, even an exemplary diabetic patient who does not miss blood glucose measurements or insulin injections cannot monitor glucose at the exact level that is obtained by the pancreas that produces the body's natural insulin. . For diabetics, the most important function of the pancreas is to make hormone insulin. A properly functioning pancreas continues to monitor blood sugar levels and respond by helping the body to release insulin in the use of glucose. Although it is possible to transplant the human pancreas, the rejection rate is high and the number of donors is limited. Therefore, more attention has been focused on finding alternatives with “artificial pancreas”.

  The artificial pancreas can continuously monitor glucose levels as the human pancreas does naturally, delivering the exact insulin dose needed in immediate response at every given moment. Insulin pumps are already available from companies such as MiniMed (California). Two types of insulin pumps are currently available. A complete implant pump embedded in the patient's abdomen and an external pump that injects insulin subcutaneously through a needle. Exemplary insulin pumps are disclosed in US Pat. Nos. 4,373,527, 4,573,994, and published European Patent Application No. EP 300,552.

  Referring to FIG. 6, a system 410 is shown that is embedded in a patient's body 90 and includes a control implant 412 and a glucose sensor 432 to provide feedback to an insulin pump 450. As described above, the insulin pump 450 may be embedded entirely within the patient 90 or may be externally attached to the body 90 with a needle (not shown) extending from the pump into the patient's body. . Once the insulin pump 450 is implanted, the control implant 412 may be coupled to the insulin pump 450, for example, directly via one or more leads, or indirectly via a wireless remote device. Alternatively, the parts of the control implant 412 may be incorporated directly into the insulin pump 450 and embedded at a desired location within the patient's body.

  The control implant 412 may include one or more components, such as an acoustic transducer, electrical circuit, memory, and / or energy source (not shown), similar to the control implant described above. The glucose sensor 432 is a dormant implant, as in the above-described embodiments, and includes an acoustic switch, an acoustic transducer, an energy source, an electrical circuit, and / or a blood glucose level measurement sensor (not shown). The glucose sensor 432 may be embedded anywhere as long as it can measure the patient's glucose concentration. The glucose sensor 432 has a relatively short service life, for example a few days now (which could be weeks or months in the future), so the glucose sensor 432 can be accessed subcutaneously, eg in the patient's abdomen, or others It is preferable to embed in the position. Thus, after the useful life expires, the whole or part of the glucose sensor 432 may be replaced with a new glucose sensor (not shown) that continues to feed back to the control implant 432 and / or the insulin pump 450.

  Accordingly, the system 410 can provide a closed loop to control the insulin rate delivered by the insulin pump 450 with frequent feedback, thereby ensuring that the patient's blood glucose concentration does not substantially vary. . The acoustic transducer (not shown) of the control implant 412 periodically sends a response command to the glucose sensor 432, which measures the patient's blood glucose concentration and via the acoustic transducer (not shown) the control implant 412. Send data back to. The control implant 412 can control the insulin delivery rate of the pump 450 in response to data obtained from the glucose sensor 432. Because the glucose sensor 432 is in a dormant state, a relatively small amount of energy is consumed by the glucose sensor 432 and the lifetime of the components of the system 410 is substantially reduced compared to systems using other communication modes, such as RF telemetry devices. Extend to. Thus, the acoustic remote device can provide a more efficient and convenient device for sending blood glucose concentration data from the glucose sensor 432 to the insulin pump 450 via the control implant 412.

Embodiments of the present invention will now be described, by way of example, with reference to the accompanying drawings.
FIG. 1 is a block diagram illustrating an exemplary embodiment of a system including two implants that can communicate with each other using acoustic telemetry. FIG. 2A is a plan view of a first embodiment of a control implant. 2B is a cross-sectional view of the control implant shown in FIG. 2A. FIG. 3 is a plan view of another embodiment of a control implant. FIG. 4 is a flowchart illustrating an exemplary communication sequence between a master implant and a slab implant. FIG. 5 is a cross-sectional view of the body showing a system for monitoring blood pressure in the body. FIG. 6 is a cross-sectional view of the body showing a closed loop system for delivering insulin in the body.

Claims (13)

A system for providing communication within a patient, the system comprising:
a) a first control implant including a first acoustic transducer for transmitting an acoustic signal ;
b) a second pause implant
Including
The second resting implant is
i) an electrical circuit configured to execute one or more commands ;
ii) a switch coupled to the electrical circuit and an energy storage device configured to supply an operating current to the electrical circuit, the switch between the active state and a dormant state; In the activated state, an operating current flows from the energy storage device to the electrical circuit, and in the resting state, an operating current flows from the energy storage device to the electrical circuit. A switch that is restricted,
a second acoustic transducer coupled to iii) said switch, said second acoustic transducer, the first is configured to receive one or more acoustic signals from the acoustic transducer, said first A second acoustic transducer, wherein the switch closes and changes the second implant from the resting state to the active state in response to the one or more acoustic signals from the acoustic transducer;
A sensor coupled to the electrical circuit for measuring at least one physiological parameter in the body and transmitting a physiological data signal to the first implant when the second implant is in an active state. With a sensor configured to
Including the system. Said switch, said second acoustic transducer receives a first acoustic excitation signal, the second acoustic excitation signal is configured to so that closed only when the subsequent first acoustic excitation signal The system of claim 1, wherein the second acoustic excitation signal is separated by a predetermined delay . It said second acoustic transducer is configured to receive a first acoustic excitation signal and a second acoustic excitation signal, the switch, the first acoustic excitation signal is the second acoustic transducer It closed when received by the switch opens when the second acoustic excitation signal to inactivate the second implant is received by the second acoustic transducer, according to claim 1 or 2. The system according to 2 . The energy storage device includes a battery system according to claim 1. The energy storage device includes a re-chargeable device, the re-chargeable device is thus re-charged to the acoustic energy received by the second acoustic transducer, according to claim 1 system. Further comprising a therapeutic device coupled to the electrical circuit, the electrical circuit is responsive to acoustic signals received from the first acoustic transducer is configured to control the therapeutic device, according to claim 1 The system described in . Said one or more commands comprises activating an actuator coupled to the electrical circuit, the actuator is configured to control the combined treatment device to the actuator, according to claim 1 system. It said second acoustic transducer is configured to receive a first acoustic excitation signal and a second acoustic excitation signal followed by the electrical circuit, as one of the predetermined set of commands said and second is configured to interpret the acoustic excitation signal, the first acoustic transducer is configured to transmit a first acoustic excitation signal and the second acoustic excitation signal followed by The system of claim 1 . The second implant further comprises a combined timer to the switch, the timer, after said switch is initially closed, and is configured to open the switch after a predetermined time has passed, The system according to claim 1 or 8 . Said first implant comprises a controller coupled to a pacemaker, the sensor includes a pressure sensor for measuring the pressure in the patient's heart, the second implant, the acoustic signals to the first implant is configured to transmit, the acoustic signal may include a pressure measured in the patient's heart, the controller extracts the measured pressure from the acoustic signal, the measured pressure The system of claim 1, wherein the system is configured to control the pacemaker based at least in part . Said first implant comprises a controller coupled to an insulin pump, the second implant comprises a glucose sensor for measuring blood sugar concentration within the patient, the second implant, the first the implant is configured to transmit an acoustic signal into the acoustic signal includes a measured blood glucose concentration value in the body of the patient, the controller, extracts the measured blood sugar concentration from the acoustic signals to, based at least in part on the measured blood glucose concentration value, it is configured to control the insulin pump system of claim 1. Wherein the first implant includes a transmitter for transmitting a memory for storing data relating to the measured physiological pharmacokinetic parameters, the data to a device located on the body outside of the patient, according to claim 1 system. Said first implant, the second performing implants and dialogue, the second implant is configured to acquire the data, the first implant, another implant by using the data has been to control the device, system according to claim 1.

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